The NDA submission was rejected in 2008 due to concerns over efficacy findings.

Kyowa Hakko Kirin announced that the Food and Drug Administration (FDA) has accepted the resubmitted New Drug Application (NDA) for istradefylline (KW-6002) for use as adjunctive treatment to levodopa/carbidopa in adults with Parkinson disease (PD) experiencing OFF episodes. The NDA submission was rejected in 2008 due to concerns over efficacy findings.

Istradefylline is an oral selective adenosine A2A receptor antagonist under investigation as a novel non-dopaminergic pharmacologic option. Adenosine A2A receptors are found in the basal ganglia of the brain where degeneration or abnormality is noted in PD; the basal ganglia are involved in motor control.

The NDA resubmission was supported by data from randomized, multicenter, double-blind, placebo-controlled trials in patients with PD taking a stable dose of levodopa/carbidopa with or without other PD medications.

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The FDA has set a target Prescription Drug User Fee Act (PDUFA) date of August 27, 2019.